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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2 Back to Search Results
Model Number 865039
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2021
Event Type  Malfunction  
Event Description

The customer reported loudspeaker error message-audio not confirmed. The device was not used for patient monitoring at the time of the alleged malfunction.

 
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Brand NameINTELLIVUE MULTI MEASUREMENT SERVER X2
Type of DeviceINTELLIVUE MULTI MEASUREMENT SERVER X2
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM 71034
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11416459
MDR Text Key242721974
Report Number9610816-2021-10012
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865039
Device Catalogue Number865039
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/25/2021
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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